Developing Capacity for Post Marketing Surveillance of Craniomaxillofacial Distractors
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Abstract
Study to determine the feasibility of using real-world data to conduct proactive post market surveillance for safety and effectiveness for craniomaxillofacial (CMF) distractors.
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This research was made possible through the generous support of the United States Food and Drug Administration .
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The National Evaluation System for health Technology Coordinating Center (NESTcc) was tasked to be a catalyst for the timely, reliable, and cost-effective development of real-world evidence to enhance regulatory and clinical decision-making for medical devices. The use of implantable devices is generally rare in pediatrics. Consequently, effective study of devices such as craniomaxillofacial CMF) distractors is not possible at single institutions, and require coordinated,interdisciplinary effort to align key outcome measures across often disparate institutions. This study tested the potential of PEDSnet to make device surveillance feasible, and to provided insight into performance in practice of several models of CMF distractors for pediatric patients.
Cohort Description
The population of interest included patients exposed to craniomaxillofacial distractors, devices used as a bone stabilizer and lengthening devices where gradual bone distraction is required (distraction osteogenesis) for mandibular/midface reconstruction of congenital defects and traumatic/oncologic defects. Comparator populations included patients exposed to CMF distractors from other manufacturers and patients undergoing facial and skull base surgical procedures without implantation of distractors.
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